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IRCT20200725048194N1 IRCT 2022-04-09 Rasht University of Medical Sciences effect of 4% Articaine and 2% Lidocaine infiltration during maxillary primary molar teeth extraction Comparison of the effect of 4% Articaine and 2% Lidocaine infiltration during maxillary primary molar teeth extraction for 6-12 year-old children 2022-03-06 anticipated 54 Complete https://irct.ir/trial/62046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize people into two groups A and B, based on the description of the work method, permutation block randomization with block size 6 is used. Based on the order in which people enter the study, part of the randomization process is given below. The complete file is available as an Excel file (SAS version 9 software was used for randomization): Seed: 21650415094698 Block sizes: 6 Actual list length: 54 block identifier, block size, sequence within block, treatment • 1, 6, 1, Group A • 1, 6, 2, Group B • 1, 6, 3, Group A • 1, 6, 4, Group B • 1, 6, 5, Group A • 1, 6, 6, Group B • 2, 6, 1, Group A To select the right and left based on the allocation specified in the previous section based on the order specified by considering the left with the letter L and the right with R, the order of selecting the direction will be as follows: Seed: 21650415094698 Block sizes: 6 Actual list length: 54 block identifier, block size, sequence within block, treatment • 1, 6, 1, Group R • 1, 6, 2, Group L • 1, 6, 3, Group R • 1, 6, 4, Group L • 1, 6, 5, Group R • 1, 6, 6, Group L • 2, 6, 1, Group R • 2, 6, 2, Group L • 2, 6, 3, Group L, Blinding description: Random sequences are placed in opaque sealed envelopes. Two blinds, an assistant evaluating the outcome, and the patient are unaware of the type of anesthetic. It is not possible for the dentist to blind the material because the injection method is different and the dentist subconsciously notices. 1-2 Comparison of the effect of 4% Articaine and 2% Lidocaine infiltration during maxillary primary molar teeth extraction for 6-12 year-old children. Intervention 1: Control group: Control group: In the first session for group A patients, injection of 1.8 ml of 4% articaine with epinephrine 1: 1000000 (Daru Pakhsh Company, Tehran, Iran) as buccal infiltration is used and and in the second session, which is at least one week away from the first session, 1.8 ml of 2% lidocaine 2% with epinephrine 1: 80,000 as buccal infiltration is used. Intervention 2: Control group: In the first session for group B patients, injection of 1.8 ml of 2% lidocaine 2% with epinephrine 1: 80,000 (Daru Pakhsh Company, Tehran, Iran) as buccal infiltration is used and and in the second session, which is at least one week away from the first session, 1.8 ml of 4% articaine with epinephrine 1: 1000000 as buccal infiltration is used. Yes - There is a plan to make this available What will be shared: Consents and work results for each person When: Start access 1 month after printing results To whom: Researchers working in academic and scientific institutions Conditions: Frequency and percentage are used to describe qualitative data And for quantitative data, mean and standard deviation will be used In addition, suitable descriptive tables and graphs will be used for both measurement scales. Shapiro-Wilk test is used to check the normality of the distribution of the groups and Levene test is used to homogenize the variances. To investigate the relationship and compare groups if the relevant assumptions are made from paired t-test and paired t-test and Generalized estimating equations (GEE) and if the assumptions are not made from Wilcoxon test and in case of no hypotheses for the GEE test, the appropriate conversions proposed by SPSS software (such as square root and logarithm) will be used to establish the hypotheses. . The software used will be spss version 26. Significance level in all tests will be considered 0.05. Where to obtain: Maryam Adham Haghighi Pour: maryamad74@gmail.com Dr. Seyedeh Hedye Daneshvar: dr.daneshvar@gums.ac.ir How to obtain: Send text to the email mentioned in the previous section using the data. Comments:
public Seyedeh Hedyeh Daneshvar
Specialized Dental Clinic, after Farhang Square,Imam Street, Rasht
Rasht Iran (Islamic Republic of) 1245632145 +98 13 3332 0060 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences scientific Seyedeh Hedyeh Daneshvar
Specialized Dental Clinic, after Farhang Square,Imam Street, Rasht
Rasht Iran (Islamic Republic of) 1245632145 +98 13 3332 0060 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Healthy children 6-12 years old who require primary maxillary molar extraction The child's cooperation is appropriate for dental treatment under local anesthesia (Class 3 or 4 Frankl scale) Consent of children's parents to participate in this study 6 years 12 years Both Allergic reaction to anesthetic solutions Having a systemic problem that interferes with the use of epinephrine-containing anesthetics Receive any medication in the last 24 hours that interferes with the assessment of pain Treatment - Drugs Treatment - Drugs Control group: Control group: In the first session for group A patients, injection of 1.8 ml of 4% articaine with epinephrine 1: 1000000 (Daru Pakhsh Company, Tehran, Iran) as buccal infiltration is used and and in the second session, which is at least one week away from the first session, 1.8 ml of 2% lidocaine 2% with epinephrine 1: 80,000 as buccal infiltration is used. Control group: In the first session for group B patients, injection of 1.8 ml of 2% lidocaine 2% with epinephrine 1: 80,000 (Daru Pakhsh Company, Tehran, Iran) as buccal infiltration is used and and in the second session, which is at least one week away from the first session, 1.8 ml of 4% articaine with epinephrine 1: 1000000 as buccal infiltration is used. Palatal anesthesia by injecting articaine infiltration alone without injecting into the palatal area. Timepoint: after extraction. Method of measurement: Selecting a higher number (1 to 5) of the Smiley Image Scale (FIS) indicates that the child is more dissatisfied. Heart beat. Timepoint: during tooth extraction. Method of measurement: pulse oximeter. Rasht University of Medical Sciences Approved 2021-11-24 ethics committee of Guilan University of Medical sciences Namjoo St. - Shahid Siadati St. - Opposite to Shahrivar Hospital - Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)